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Class III · Lower riskRecall completed

Contrave

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: ZCXM, Exp 01NOV2020; ZCXN, Exp 02NOV2020; ZCXP, Exp 09NOV2020; ZCXS, 10NOV2020; ZCXT, Exp 13NOV2020; and ZCXV, Exp 17NOV2020
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Defective Container: Customer complaints of punctures in the bottle.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byNalpropion Pharmaceuticals LLC
Brand nameCONTRAVE
Generic nameNALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE
Active ingredient(s)BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
Distributed by / forOrexigen therapeutics, Inc., La Jolla, CA 92037
NDC51267-890-99
Show the full FDA record
Full product labelContrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99.
Recalling firmOrexigen Therapeutics, Inc.
DistributionNationwide in the USA
Quantity95,296 bottles
Recall initiated2018-08-09
Report date2018-08-22
Recall completed2019-11-15
Recall numberD-1099-2018
ClassificationClass III
FDA statusTerminated
Origin on fileLa Jolla CA United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.